{
"NDC": [
{
"NDCCode": "42829-550-32",
"PackageDescription": "1 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE",
"NDC11Code": "42829-0550-32",
"ProductNDC": "42829-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zilactin-b",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251106",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain caused by: 1 canker sores, 2 minor mouth sores and gum irritations, 3 denture and brace pain."
},
{
"NDCCode": "50486-550-32",
"PackageDescription": "1 TUBE in 1 CARTON (50486-550-32) / 7 g in 1 TUBE",
"NDC11Code": "50486-0550-32",
"ProductNDC": "50486-550",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zilactin-b",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20050629",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Blairex Laboratories, Inc.",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050629",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves pain caused by: : 1 canker sores , 2 minor mouth sores and gum irritations , 3 denture and brace pain ."
},
{
"NDCCode": "52807-101-32",
"PackageDescription": "550 mL in 1 BOTTLE (52807-101-32) ",
"NDC11Code": "52807-0101-32",
"ProductNDC": "52807-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangdong Longtai Industry Co.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skinre commended for repeated use."
},
{
"NDCCode": "52807-102-32",
"PackageDescription": "550 mL in 1 BOTTLE (52807-102-32) ",
"NDC11Code": "52807-0102-32",
"ProductNDC": "52807-102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200320",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangdong Longtai Industry Co.,LTD",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "For hand washing to decrease bacteria on the skinre commended for repeated use."
},
{
"NDCCode": "60687-491-01",
"PackageDescription": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-491-01) / 1 TABLET in 1 BLISTER PACK (60687-491-11) ",
"NDC11Code": "60687-0491-01",
"ProductNDC": "60687-491",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "American Health Packaging",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200218",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration: 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration: 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol."
},
{
"NDCCode": "61919-376-14",
"PackageDescription": "14 TABLET in 1 BOTTLE (61919-376-14) ",
"NDC11Code": "61919-0376-14",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-20",
"PackageDescription": "20 TABLET in 1 BOTTLE (61919-376-20) ",
"NDC11Code": "61919-0376-20",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-28",
"PackageDescription": "28 TABLET in 1 BOTTLE (61919-376-28) ",
"NDC11Code": "61919-0376-28",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (61919-376-30) ",
"NDC11Code": "61919-0376-30",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (61919-376-45) ",
"NDC11Code": "61919-0376-45",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (61919-376-60) ",
"NDC11Code": "61919-0376-60",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Direct RX",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis, 5 For relief of the signs and symptoms of tendonitis, 6 For relief of the signs and symptoms of bursitis, 7 For relief of the signs and symptoms of acute gout, 8 For the management of pain, 9 For the management of primary dysmenorrhea.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "61919-376-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (61919-376-90) ",
"NDC11Code": "61919-0376-90",
"ProductNDC": "61919-376",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078250",
"LabelerName": "Direct_Rx",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.",
"Description": "Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH."
},
{
"NDCCode": "24385-121-01",
"PackageDescription": "1 KIT in 1 KIT (24385-121-01) * 3000 mg in 1 PACKET (42829-998-00) ",
"NDC11Code": "24385-0121-01",
"ProductNDC": "24385-121",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Tip Squeeze Bottle Sinus Wash",
"ProprietaryNameSuffix": "Good Neighbor Pharmacy",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20220109",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AMERISOURCE BEGEN",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "24385-267-10",
"PackageDescription": "1 KIT in 1 BOX (24385-267-10) * 3000 mg in 1 PACKET (42829-998-00) ",
"NDC11Code": "24385-0267-10",
"ProductNDC": "24385-267",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinus Wash Saline Packets",
"ProprietaryNameSuffix": "Good Neighbor Pharmacy",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20220108",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AMERISOURCE BEGEN",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220108",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "24385-451-01",
"PackageDescription": "1 KIT in 1 KIT (24385-451-01) * 3000 mg in 1 PACKET (42829-998-00) ",
"NDC11Code": "24385-0451-01",
"ProductNDC": "24385-451",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Tip Neti Pot",
"ProprietaryNameSuffix": "Good Neighbor Pharmacy",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20220109",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AMERISOURCE BEGEN",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "41520-929-30",
"PackageDescription": "1 KIT in 1 KIT (41520-929-30) * 3000 mg in 1 PACKET (42829-998-00) ",
"NDC11Code": "41520-0929-30",
"ProductNDC": "41520-929",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soft Tip Neti Pot Sinus Wash",
"ProprietaryNameSuffix": "Careone",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20220109",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "FOODHOLD U.S.A.",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220109",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-001-12",
"PackageDescription": "127 g in 1 BOTTLE, SPRAY (42829-001-12) ",
"NDC11Code": "42829-0001-12",
"ProductNDC": "42829-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sterile Saline Kids Mist",
"ProprietaryNameSuffix": "Sinucleanse Breathe",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20220613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".9",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2022-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220613",
"SamplePackage": "N",
"IndicationAndUsage": "Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-002-21",
"PackageDescription": "211 g in 1 BOTTLE (42829-002-21) ",
"NDC11Code": "42829-0002-21",
"ProductNDC": "42829-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Wound Care",
"ProprietaryNameSuffix": "Medicleanse Healing",
"NonProprietaryName": "Benzethonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220628",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "BENZETHONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2023-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220628",
"SamplePackage": "N",
"IndicationAndUsage": "First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns."
},
{
"NDCCode": "42829-003-12",
"PackageDescription": "127 g in 1 BOTTLE, SPRAY (42829-003-12) ",
"NDC11Code": "42829-0003-12",
"ProductNDC": "42829-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sterile Saline Kids Mist",
"ProprietaryNameSuffix": "Pediameds",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20220613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".9",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2022-08-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220613",
"SamplePackage": "N",
"IndicationAndUsage": "Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-401-01",
"PackageDescription": "3000 mg in 1 PACKET (42829-401-01) ",
"NDC11Code": "42829-0401-01",
"ProductNDC": "42829-401",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"SubstanceName": "SODIUM BICARBONATE; SODIUM CHLORIDE",
"StrengthNumber": "700; 2300",
"StrengthUnit": "mg/3000mg; mg/3000mg",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-402-30",
"PackageDescription": "1 KIT in 1 KIT (42829-402-30) * 3000 mg in 1 PACKET (42829-401-01) ",
"NDC11Code": "42829-0402-30",
"ProductNDC": "42829-402",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse Neti-pot",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-405-30",
"PackageDescription": "1 KIT in 1 KIT (42829-405-30) * 3000 mg in 1 PACKET (42829-401-01) ",
"NDC11Code": "42829-0405-30",
"ProductNDC": "42829-405",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse Squeeze",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "KIT",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-406-30",
"PackageDescription": "1 KIT in 1 KIT (42829-406-30) * 30 PACKET in 1 KIT (42829-401-02) / 3000 mg in 1 PACKET",
"NDC11Code": "42829-0406-30",
"ProductNDC": "42829-406",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse Micro-filtered Nasal Wash System",
"NonProprietaryName": "Sodium Chloride, Sodium Bicarbonate",
"DosageFormName": "KIT",
"StartMarketingDate": "20150701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-407-10",
"PackageDescription": "30 mL in 1 BOTTLE, SPRAY (42829-407-10) ",
"NDC11Code": "42829-0407-10",
"ProductNDC": "42829-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse Nasal Drip",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "GEL",
"RouteName": "NASAL",
"StartMarketingDate": "20220108",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": ".9",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2022-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220108",
"SamplePackage": "N",
"IndicationAndUsage": "Provides moisture to soothe and hydrate dry nasal passages caused by Indoor heat, dry climate, air travel, high altitude, oxygen use, CPAP machineuse."
},
{
"NDCCode": "42829-408-00",
"PackageDescription": "100 PACKET in 1 CARTON (42829-408-00) / 3000 mg in 1 PACKET",
"NDC11Code": "42829-0408-00",
"ProductNDC": "42829-408",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"SubstanceName": "SODIUM BICARBONATE; SODIUM CHLORIDE",
"StrengthNumber": "22.2; 77.8",
"StrengthUnit": "mg/100mg; mg/100mg",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-408-60",
"PackageDescription": "60 PACKET in 1 CARTON (42829-408-60) / 3000 mg in 1 PACKET",
"NDC11Code": "42829-0408-60",
"ProductNDC": "42829-408",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sinucleanse",
"NonProprietaryName": "Sodium Bicarbonate, Sodium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "NASAL",
"StartMarketingDate": "20150201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC.",
"SubstanceName": "SODIUM BICARBONATE; SODIUM CHLORIDE",
"StrengthNumber": "22.2; 77.8",
"StrengthUnit": "mg/100mg; mg/100mg",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages."
},
{
"NDCCode": "42829-468-02",
"PackageDescription": "1 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE",
"NDC11Code": "42829-0468-02",
"ProductNDC": "42829-468",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zilactin",
"ProprietaryNameSuffix": "Early Relief Cold Sore",
"NonProprietaryName": "Benzyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "ASCENT CONSUMER PRODUCTS, INC",
"SubstanceName": "BENZYL ALCOHOL",
"StrengthNumber": ".1",
"StrengthUnit": "g/g",
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<NDC>
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<NDC>
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<PackageDescription>550 mL in 1 BOTTLE (52807-101-32) </PackageDescription>
<NDC11Code>52807-0101-32</NDC11Code>
<ProductNDC>52807-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SubstanceName>ALCOHOL</SubstanceName>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>52807-102-32</NDCCode>
<PackageDescription>550 mL in 1 BOTTLE (52807-102-32) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SubstanceName>ALCOHOL</SubstanceName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For hand washing to decrease bacteria on the skinre commended for repeated use.</IndicationAndUsage>
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<NDC>
<NDCCode>60687-491-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-491-01) / 1 TABLET in 1 BLISTER PACK (60687-491-11) </PackageDescription>
<NDC11Code>60687-0491-01</NDC11Code>
<ProductNDC>60687-491</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200218</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets, USP and Naproxen Sodium Tablets, USP are nonsteroidal anti-inflammatory drugs available as follows. Naproxen Tablets, USP are available as follows for oral administration: 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. The inactive ingredients are croscarmellose sodium, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose and povidone. Naproxen Sodium Tablets, USP are available as follows for oral administration: 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains FD&C blue#2, iron oxide red, hypromellose, polyethylene glycol and titanium dioxide. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 g/mol and a molecular formula of C 14H 14O 3. Naproxen sodium, USP has a molecular weight of 252.24 g/mol and a molecular formula of C 14H 13NaO 3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively:. Naproxen, USP is a white to off-white crystalline powder. It is soluble in chloroform, dehydrated alcohol and alcohol; sparingly soluble in ether, insoluble in water. Naproxen sodium, USP is a white to almost white crystalline powder, soluble in water and methanol; sparingly soluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-14</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE (61919-376-14) </PackageDescription>
<NDC11Code>61919-0376-14</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (61919-376-20) </PackageDescription>
<NDC11Code>61919-0376-20</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-28</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (61919-376-28) </PackageDescription>
<NDC11Code>61919-0376-28</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (61919-376-30) </PackageDescription>
<NDC11Code>61919-0376-30</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (61919-376-45) </PackageDescription>
<NDC11Code>61919-0376-45</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (61919-376-60) </PackageDescription>
<NDC11Code>61919-0376-60</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Direct RX</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis, 2 For the relief of the signs and symptoms of osteoarthritis, 3 For the relief of the signs and symptoms of ankylosing spondylitis, 4 For the relief of the signs and symptoms of juvenile arthritis, 5 For relief of the signs and symptoms of tendonitis, 6 For relief of the signs and symptoms of bursitis, 7 For relief of the signs and symptoms of acute gout, 8 For the management of pain, 9 For the management of primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>61919-376-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (61919-376-90) </PackageDescription>
<NDC11Code>61919-0376-90</NDC11Code>
<ProductNDC>61919-376</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078250</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Naproxen tablets and naproxen sodium tablets are indicated for. The relief of the signs and symptoms of. rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis.</IndicationAndUsage>
<Description>Naproxen Tablets USP and Naproxen Sodium Tablets USP are nonsteroidal anti-inflammatory drugs available as follows: Naproxen Tablets USP are available as follows for oral administration. 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one. side and ‘250’ on the other side. 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. The inactive ingredients are microcrystalline cellulose, croscarmellose sodium, iron oxide red, iron oxide yellow, povidone and magnesium stearate. Naproxen Sodium Tablets USP are available as follows for oral administration. 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. The inactive ingredients are croscarmellose sodium, colloidal silicon dioxide, povidone, magnesium stearate, microcrystalline cellulose and talc. The coating suspension for the naproxen sodium 275 mg and 550 mg tablet contains hypromellose, titanium dioxide, polyethylene glycol, FD&C blue#2, and iron oxide red. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical names for naproxen, USP and naproxen sodium, USP are (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid and (S)-6methoxy-α-methyl-2-naphthaleneacetic acid, sodium salt, respectively. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen sodium, USP has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen, USP and naproxen sodium, USP have the following structures, respectively. [Structural Formula]. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Naproxen sodium, USP is a white to creamy white, crystalline solid, freely soluble in water at neutral pH.</Description>
</NDC>
<NDC>
<NDCCode>24385-121-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24385-121-01) * 3000 mg in 1 PACKET (42829-998-00) </PackageDescription>
<NDC11Code>24385-0121-01</NDC11Code>
<ProductNDC>24385-121</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Tip Squeeze Bottle Sinus Wash</ProprietaryName>
<ProprietaryNameSuffix>Good Neighbor Pharmacy</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AMERISOURCE BEGEN</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24385-267-10</NDCCode>
<PackageDescription>1 KIT in 1 BOX (24385-267-10) * 3000 mg in 1 PACKET (42829-998-00) </PackageDescription>
<NDC11Code>24385-0267-10</NDC11Code>
<ProductNDC>24385-267</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinus Wash Saline Packets</ProprietaryName>
<ProprietaryNameSuffix>Good Neighbor Pharmacy</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AMERISOURCE BEGEN</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24385-451-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24385-451-01) * 3000 mg in 1 PACKET (42829-998-00) </PackageDescription>
<NDC11Code>24385-0451-01</NDC11Code>
<ProductNDC>24385-451</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Tip Neti Pot</ProprietaryName>
<ProprietaryNameSuffix>Good Neighbor Pharmacy</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AMERISOURCE BEGEN</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41520-929-30</NDCCode>
<PackageDescription>1 KIT in 1 KIT (41520-929-30) * 3000 mg in 1 PACKET (42829-998-00) </PackageDescription>
<NDC11Code>41520-0929-30</NDC11Code>
<ProductNDC>41520-929</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soft Tip Neti Pot Sinus Wash</ProprietaryName>
<ProprietaryNameSuffix>Careone</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220109</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>FOODHOLD U.S.A.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-001-12</NDCCode>
<PackageDescription>127 g in 1 BOTTLE, SPRAY (42829-001-12) </PackageDescription>
<NDC11Code>42829-0001-12</NDC11Code>
<ProductNDC>42829-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sterile Saline Kids Mist</ProprietaryName>
<ProprietaryNameSuffix>Sinucleanse Breathe</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-002-21</NDCCode>
<PackageDescription>211 g in 1 BOTTLE (42829-002-21) </PackageDescription>
<NDC11Code>42829-0002-21</NDC11Code>
<ProductNDC>42829-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Wound Care</ProprietaryName>
<ProprietaryNameSuffix>Medicleanse Healing</ProprietaryNameSuffix>
<NonProprietaryName>Benzethonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220628</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-003-12</NDCCode>
<PackageDescription>127 g in 1 BOTTLE, SPRAY (42829-003-12) </PackageDescription>
<NDC11Code>42829-0003-12</NDC11Code>
<ProductNDC>42829-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sterile Saline Kids Mist</ProprietaryName>
<ProprietaryNameSuffix>Pediameds</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-08-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-401-01</NDCCode>
<PackageDescription>3000 mg in 1 PACKET (42829-401-01) </PackageDescription>
<NDC11Code>42829-0401-01</NDC11Code>
<ProductNDC>42829-401</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<SubstanceName>SODIUM BICARBONATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>700; 2300</StrengthNumber>
<StrengthUnit>mg/3000mg; mg/3000mg</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-402-30</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42829-402-30) * 3000 mg in 1 PACKET (42829-401-01) </PackageDescription>
<NDC11Code>42829-0402-30</NDC11Code>
<ProductNDC>42829-402</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Neti-pot</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-405-30</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42829-405-30) * 3000 mg in 1 PACKET (42829-401-01) </PackageDescription>
<NDC11Code>42829-0405-30</NDC11Code>
<ProductNDC>42829-405</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Squeeze</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Nasal Stuffiness. -Runny nose. -Post nasal drip. Removes inhaled irritants (dust, pollen). Removes nasal and sinus drainage. Helps reduce swelling of nasal membranes. Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-406-30</NDCCode>
<PackageDescription>1 KIT in 1 KIT (42829-406-30) * 30 PACKET in 1 KIT (42829-401-02) / 3000 mg in 1 PACKET</PackageDescription>
<NDC11Code>42829-0406-30</NDC11Code>
<ProductNDC>42829-406</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Micro-filtered Nasal Wash System</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-407-10</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, SPRAY (42829-407-10) </PackageDescription>
<NDC11Code>42829-0407-10</NDC11Code>
<ProductNDC>42829-407</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Nasal Drip</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Provides moisture to soothe and hydrate dry nasal passages caused by Indoor heat, dry climate, air travel, high altitude, oxygen use, CPAP machineuse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-408-00</NDCCode>
<PackageDescription>100 PACKET in 1 CARTON (42829-408-00) / 3000 mg in 1 PACKET</PackageDescription>
<NDC11Code>42829-0408-00</NDC11Code>
<ProductNDC>42829-408</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<SubstanceName>SODIUM BICARBONATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>22.2; 77.8</StrengthNumber>
<StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-408-60</NDCCode>
<PackageDescription>60 PACKET in 1 CARTON (42829-408-60) / 3000 mg in 1 PACKET</PackageDescription>
<NDC11Code>42829-0408-60</NDC11Code>
<ProductNDC>42829-408</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate, Sodium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20150201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC.</LabelerName>
<SubstanceName>SODIUM BICARBONATE; SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>22.2; 77.8</StrengthNumber>
<StrengthUnit>mg/100mg; mg/100mg</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves symptoms associated with. sinusitis, cold, flu or allergies. -Sneezing. -Runny nose. -Nasal stuffiness. -Post nasal drip. -Removes inhaled irritants (dust, pollen). -Promotes nasal and sinus drainage. -Helps reduce swelling of nasal membranes. -Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-468-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42829-468-02) / 7 g in 1 TUBE</PackageDescription>
<NDC11Code>42829-0468-02</NDC11Code>
<ProductNDC>42829-468</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zilactin</ProprietaryName>
<ProprietaryNameSuffix>Early Relief Cold Sore</ProprietaryNameSuffix>
<NonProprietaryName>Benzyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>BENZYL ALCOHOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Pediculicide [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves pain caused by: 1 cold sores/fever blisters, 2 canker sores, mouth sores, 3 gum irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-504-45</NDCCode>
<PackageDescription>127 g in 1 BOTTLE, SPRAY (42829-504-45) </PackageDescription>
<NDC11Code>42829-0504-45</NDC11Code>
<ProductNDC>42829-504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Sterile Saline Mist Daily Care</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-504-75</NDCCode>
<PackageDescription>213 g in 1 BOTTLE, SPRAY (42829-504-75) </PackageDescription>
<NDC11Code>42829-0504-75</NDC11Code>
<ProductNDC>42829-504</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Sterile Saline Mist Daily Care</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220108</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42829-505-60</NDCCode>
<PackageDescription>129 g in 1 BOTTLE, SPRAY (42829-505-60) </PackageDescription>
<NDC11Code>42829-0505-60</NDC11Code>
<ProductNDC>42829-505</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sinucleanse Sterile Saline Mist</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>ASCENT CONSUMER PRODUCTS, INC</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nasal congestion. Removes inhaled irritants (dust, dirt, pollen). Moisturizes dry nasal passages.</IndicationAndUsage>
</NDC>
</NDCList>